Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 75
Clinical summary
Summary
Lenalidomide and Azacitidine each have clear evidence of efficacy in MDS, and have shown activity in AML. However, not all patients respond so better regimens, including combinations, are required. MDS and AML are heterogeneous diseases, and lenalidomide and azacitidine may target different cellular populations and induce differing clinical responses. Combinations of immunomodulatory drugs and azacitidine have been explored and shown to be feasible. This is an open label, multi-centre, randomised Phase II study exploring the toxicity and efficacy of the combination of lenalidomide and 5azacitidine compared to 5azacitidine alone. Patients will be randomised 1:1 to either combination 5azacitidine and lenalidomide (5azacitidine 75mg/m2/day x5days of a 28 day cycle + lenalidomide commencing cycle 3 10mg/dayx21days of a 28 day cycle) or 5azacitidine alone (75mg/m2/day x7days over 9days of a 28 day cycle; 5-2-2 regimen) for 12 months to primary endpoint, then all patients may continue 5azacitidine alone until progression or toxicity. Response will be determined by peripheral blood counts, transfusions, bone marrow morphology and cytogenetics, according to IWG criteria. The study also incorporates a correlative laboratory component designed to determine the mechanism of action of 5azacitidine +/- lenalidomide and to determine a baseline profile which may predict those most responsive. These studies will incorporate gene methylation and expression, and enumeration of lymphocyte subsets, natural killer cell function and cytokine profiles.
Conditions
This trial is treating people with Acute Myeloid Leukaemia, Myelodysplasia
Eligibility
Inclusion
Disease diagnosis of either MDS (by World Health Organisation criteria, those with refractory anaemia and Refractory Anaemia with Ringed Sideroblasts to also have at least one clinically significant cytopenia), nonproliferative Chronic Myelomonocytic Leukaemia (CMML) or low marrow blast count AML; Eastern Cooperative Oncology Group (ECOG) 2 or less with life expectancy at least 3 months, adequate contraception and adequate renal and hepatic function, written informed consent.
Exclusion
Prior chemotherapy for MDS or AML except low dose cytarabine or hydroxyurea, any prior demethylating agent or immunomodulatory drug (including thalidomide or lenalidomide), prior diagnosis of cancer except with low risk of recurrence, significant renal, hepatic, cardiac or respiratory disease or severe active infection.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).
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